API Regulatory Compliance Lead

Full-time Business Operations Specialists

We’re hiring API - Regulatory Affairs professionals!

Join us to drive global DMF submissions, regulatory compliance, and strategic market access.

📍 Apply now and grow with a high-impact team. We are seeking a dynamic and detail-oriented professional to manage end-to-end regulatory submissions and lifecycle activities for API dossiers across global markets. The role plays a critical part in ensuring timely approvals, regulatory compliance, and seamless coordination across functions.

Regulatory Submissions & DMF Management :

• Prepare, review, and submit Drug Master Files (DMFs) in compliance with global regulatory requirements and Manage full DMF lifecycle including amendments, annual updates, and variations
• Ensure timely submission of regulatory dossiers and responses to health authorities
• Maintain accurate tracking and documentation of DMFs, LOAs...